EN 1060-3:1997+A2:2009
(Main + Amendment)Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
General Information
- Abstract
This Part of EN 1060 specifies performance, efficiency and safety requirements for electro-mechanical blood pressure measuring systems that, by means of an inflatable cuff are used for non-invasive measurements of arterial blood pressure at the upper arm, the wrist and the thigh. It also specifies requirements for their accessories and gives test methods.
This Part of EN 1060 applies to electro-mechanical blood pressure measuring systems in which the cuff pressure is measured electronically, but in which the blood pressure can be determined either manually with the aid of a stethoscope or automatically.
Additional safety requirements for automatic cycling indirect blood pressure monitoring equipment are specified in EN 60601-2-30:1995.
This Part of EN 1060 is to be used in conjunction with EN 1060-1.
- Status
- Withdrawn
- Publication Date
- 17-Nov-2009
- Withdrawal Date
- 16-Sep-2026
- Technical Committee
- CEN/TC 205 - Non-active medical devices
- Drafting Committee
- CEN/TC 205/WG 10 - Non-invasive sphygmomanometers
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 25-Apr-2018
- Completion Date
- 17-Sep-2026
Not Harmonized93/42/EEC - Medical devicesOJ Ref: C, C 183 OJ Date: 07-Jul-2010
Relations
- Effective Date
- 19-Jan-2023
- Effective Date
- 26-Sep-2009
- Effective Date
- 26-Sep-2009
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN 1060-3:1997+A2:2009 is a standard published by the European Committee for Standardization (CEN). Its full title is "Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems". This standard covers: This Part of EN 1060 specifies performance, efficiency and safety requirements for electro-mechanical blood pressure measuring systems that, by means of an inflatable cuff are used for non-invasive measurements of arterial blood pressure at the upper arm, the wrist and the thigh. It also specifies requirements for their accessories and gives test methods. This Part of EN 1060 applies to electro-mechanical blood pressure measuring systems in which the cuff pressure is measured electronically, but in which the blood pressure can be determined either manually with the aid of a stethoscope or automatically. Additional safety requirements for automatic cycling indirect blood pressure monitoring equipment are specified in EN 60601-2-30:1995. This Part of EN 1060 is to be used in conjunction with EN 1060-1.
This Part of EN 1060 specifies performance, efficiency and safety requirements for electro-mechanical blood pressure measuring systems that, by means of an inflatable cuff are used for non-invasive measurements of arterial blood pressure at the upper arm, the wrist and the thigh. It also specifies requirements for their accessories and gives test methods. This Part of EN 1060 applies to electro-mechanical blood pressure measuring systems in which the cuff pressure is measured electronically, but in which the blood pressure can be determined either manually with the aid of a stethoscope or automatically. Additional safety requirements for automatic cycling indirect blood pressure monitoring equipment are specified in EN 60601-2-30:1995. This Part of EN 1060 is to be used in conjunction with EN 1060-1.
EN 1060-3:1997+A2:2009 is classified under the following ICS (International Classification for Standards) categories: 11.040.55 - Diagnostic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 1060-3:1997+A2:2009 has the following relationships with other standards: It is inter standard links to EN 1060-3:1997/FprA2, EN 1060-3:1997, EN 1060-3:1997/A1:2005, EN 60601-1:2006, EN 60601-1-8:2007, EN 60601-2-30:2000, EN 60601-1-2:2015, EN 1060-1:1995, EN ISO 81060-2:2019, EN 1060-2:1995, EN ISO 10456:2007, EN ISO 15758:2014, EN ISO 13788:2001. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1060-3:1997+A2:2009 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 1060-3:1997+A2:2009 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Neinvazivni sfigmomanometri - 3. del: Dodatne zahteve za avtomatizirane sisteme za merjenje krvnega tlakaNichtinvasive Blutdruckmessgeräte - Teil 3: Ergänzende Anforderungen für elektromechanische BlutdruckmesssystemeTensiomètres non invasifs - Partie 3: Exigences complémentaires concernant les systèmes électromécaniques de mesure de la pression sanguineNon-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:EN 1060-3:1997+A2:2009SIST EN 1060-3:2000+A2:2010en,fr,de01-marec-2010SIST EN 1060-3:2000+A2:2010SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1060-3:1997+A2
November 2009 ICS 11.040.55 Supersedes EN 1060-3:1997English Version
Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
Tensiomètres non invasifs - Partie 3: Exigences complémentaires concernant les systèmes électromécaniques de mesure de la pression sanguine
Nichtinvasive Blutdruckmessgeräte - Teil 3: Ergänzende Anforderungen für elektromechanische Blutdruckmesssysteme This European Standard was approved by CEN on 27 January 1997 and includes Amendment 1 approved by CEN on 24 November 2005 and Amendment 2 approved by CEN on 17 October 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1060-3:1997+A2:2009: ESIST EN 1060-3:2000+A2:2010
Bibliography . 22Annex ZA (informative)
####Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices$$$$ . 23 SIST EN 1060-3:2000+A2:2010
!" and # $. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. This European Standard 'Non-invasive sphygmomanometers' consists of the following parts: Part 1: General requirements Part 2: Supplementary requirements for mechanical sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive 93/42/EEC. #Annexes A and ZA are given for information and do not form normative parts of this European Standard.$ According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
These normative references are cited at the appropriate places in the text and the publications are listed hereafter.
For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision.
For undated references the latest edition of the publication referred to applies. #deleted text$ EN 1060-1:1995, Non-invasive sphygmomanometers – Part 1: General requirements EN 1060-2:1995, Non-invasive sphygmomanometers – Part 2: Supplementary requirements for mechanical sphygmomanometers !EN 1060-4:2004, Non-invasive sphygmomanometers – Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers" #EN 60601-1:2006, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance$ #EN 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests$ #EN 60601-1-8, Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems$ !EN 60601-2-30:2000, Medical electrical equipment – Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
(IEC 60601-2-30:1999)" 3 Definitions !For the purposes of this document, the terms and definitions given in EN 1060-1:1995, EN 1060-2:1995, #EN 60601-1:2006$ and the following apply." SIST EN 1060-3:2000+A2:2010
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